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Re: Jonjones325 post# 464645

Monday, 07/22/2024 10:41:42 PM

Monday, July 22, 2024 10:41:42 PM

Post# of 468830
The MAA should have been submitted by now and the company has chosen not to PR that. Given the history of the company on PRing dealings with regulators and the regulation process I doubt that they will.

Your theory about taking a chance and a possible no answer would be a setback for sure. Just like Rett was a setback. It is an unavoidable risk in the drug development process.

At some point the company has to apply for drug approval. I do expect that we will get a PR when the NDA is filed with the FDA. I wonder if Anavex will wait for the initial CHMP evaluation of the MAA to see what, if any, questions the CHMP has so they can be addressed in the NDA prior to filing.

Nunc est Bibendum

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